BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 13153610 · Received January 4, 2022

    Report

    Report Number
    9610825-2021-00547
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    November 14, 2021
    Report Date
    April 22, 2022
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). A VISUAL INSPECTION WAS PERFORMED. NO DAMAGE COULD BE FOUND. A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF TEST. A SPACE LINE WAS INSERTED, AND THE PUMP IDENTIFIED THE LINE AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. THE DEVICE HISTORY FILES WERE READ AND ANALYZED. NO ABNORMALITIES WERE FOUND IN THE DEVICE HISTORY. THE DOWNSTREAM-SENSOR THE ELECTRONIC PRESSURE CUT-OFF AND THE MECHANICAL PRESSURE LIMITATION OF THE DEVICE WERE TESTED ACCORDING TO THE REQUIREMENTS OF THE TECHNICAL SAFETY CHECK. FURTHERMORE THE PRESSURE STABILITY OF THE SAFETY CLAMP CONCERNING THE PERCOLATION (FREE FLOW POSSIBILITY) WAS CHECKED. THE DEVICE MATCHED THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES WERE WITHIN OUR SPECIFICATION. A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FEED RATE OF 100 ML/H WAS CHOSEN. THE ASSESSED MEAN DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF -1,66%. DURING THE INVESTIGATION NO FAULTS COULD BE DETECTED, TO INVESTIGATE THE INSIDE OF THE DEVICE, ONLY THE UPPER HOUSING WAS REMOVED. NO DAMAGE OR SOILING COULD BE FOUND. THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATED WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4): "UNDERINFUSION". REASON OF COMPLAINT: "PUMP STATES INFUSING, ARROWS MOVING, BUT NO INFUSION DRIPPING INTO THE GIVING SET CHAMBER BEFORE THE PUMP. INCORRECT AMOUNT OF VOLUME GIVEN REGISTERED ON PUMP. MET AND SPOKE WITH (B)(6) EMERGENCY DEPT WHO THIS WAS REPORTED TO THE DAY AFTER IT OCCURRED. THEIR INTERNAL REPORT DOES NOT INDICATE THE NURSING STAFF WHO LOGGED THE REPORT. IT DOES NOT INDICATE ANY FURTHER INFORMATION OTHER THAN PUMP STATES INFUSING, ARROWS MOVING, BUT NO INFUSION DRIPPING INTO THE GIVING SET CHAMBER BEFORE THE PUMP. INCORRECT AMOUNT OF VOLUME GIVEN REGISTERED ON PUMP. HE IS NOT ABLE TO IDENTIFY THE LINE SET USED NOR BATCH/LOT. THERE IS NO INDICATION IF THE DL WAS BEING USED OR WHAT MEDICATION WAS BEING INFUSED. THERE IS NO INDICATION IF ANY RISK OR HARM TO THE PATIENT FOLLOWING THE REDUCED VOLUME DELIVERED. AS THE DESCRIPTION INFERS THE AMOUNT DELIVERED IS INCORRECT THE BIOMEDICAL DEPT WOULD LIKE THE PUMP CHECKED FOR FLOW ACCURACY."

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN AUSTRALIA: "UNDERINFUSION" REASON OF COMPLAINT: "PUMP STATES INFUSING, ARROWS MOVING, BUT NO INFUSION DRIPPING INTO THE GIVING SET CHAMBER BEFORE THE PUMP. INCORRECT AMOUNT OF VOLUME GIVEN REGISTERED ON PUMP. MET AND SPOKE WITH CIPRIAN IOCAB CNC EMERGENCY DEPT WHO THIS WAS REPORTED TO THE DAY AFTER IT OCCURRED. THEIR INTERNAL REPORT DOES NOT INDICATE THE NURSING STAFF WHO LOGGED THE REPORT. IT DOES NOT INDICATE ANY FURTHER INFORMATION OTHER THAN PUMP STATES INFUSING, ARROWS MOVING, BUT NO INFUSION DRIPPING INTO THE GIVING SET CHAMBER BEFORE THE PUMP. INCORRECT AMOUNT OF VOLUME GIVEN REGISTERED ON PUMP. HE IS NOT ABLE TO IDENTIFY THE LINE SET USED NOR BATCH/LOT. THERE IS NO INDICATION IF THE DL WAS BEING USED OR WHAT MEDICATION WAS BEING INFUSED. THERE IS NO INDICATION IF ANY RISK OR HARM TO THE PATIENT FOLLOWING THE REDUCED VOLUME DELIVERED. AS THE DESCRIPTION INFERS THE AMOUNT DELIVERED IS INCORRECT THE BIOMEDICAL DEPT WOULD LIKE THE PUMP CHECKED FOR FLOW ACCURACY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225623 INFUSOMAT SPACE PUMP, INFUSION, PRODUCT CODE: FRN FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown